Aortic Aneurysm, ThoracicVCOUSNCT01181947

VALIANT CAPTIVIA Post-market Registry

An observational study of Aortic Aneurysm, Thoracic, run by Medtronic Cardiovascular at 15 sites in 7 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

The Valiant Thoracic Stent Graft has been preloaded on the new Captivia Delivery System (Captivia). This new delivery system was CE marked on September 14th, 2009 and was commercially released in the European Union on October 1st, 2009. Read more about this study

Who is it for?: Any age
Conditions the study is for: Aortic Aneurysm, Thoracic
What is being tested?: TEVAR
Type of treatment: Medical device
How many people: 100 participants
Where: 15 sitesin 7 countries
Study dates: Feb 2010to Aug 2013
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: The Valiant Thoracic Stent Graft with the Captivia Delivery System is indicated for treatment of diseases of the descending thoracic aorta including but not limited to aneurysms and dissections. The Valiant Thoracic Stent Graft is indicated for exclusion of the aneurysm, the false lumen or site of rupture and restoration of blood flow through the stent graft lumen. The device is intended for use in subjects who are candidates for conventional surgical repair, and in subjects who are not candidates for conventional surgical repair due to pre-existing risk factors. Study enrolment is open to subjects who in the opinion of the investigator are candidates for endovascular TAA repair with the Valiant Captivia Thoracic Stent Graft System according to the instructions for use (IFU).

Who may be able to join

Age ≥ 18 years or minimum age as required by local regulations
Indication for surgical repair of thoracic aortic aneurysms and/or thoracic aortic dissections with an thoracic endovascular stent graft in accordance with the applicable guidelines on endovascular interventions and the Instructions for Use of the Valiant Captivia Thoracic Stent Graft System
Signed consent form ('Patient informed consent form' or 'Patient Data Release Authorization Form')
Intention to implant the Valiant Captivia Thoracic Stent Graft System or having implanted the system within the last 3 months before subject enrollment
Willingness and ability to comply with the CIP

Who cannot join

High probability of non-adherence to physician's follow-up requirements
Participation in concurrent interventional trial which may confound study results
Prior implantation of a thoracic stent graft

Trial locations and contacts

15 sites in 7 countries.

Country

City, postcode or hospital

15 sites in 7 countries

Germany6 sites

Klinikum der J.W.Goethe-Universitat
Frankfurt am Main, D-60590
Klinikum der Johann-Wolfgang-Goethe - Institut fur Diagnostische und Interventionelle Radiologie
Frankfurt am Main, D-60590
Medizinische Hochschule Hannover
Hanover, 30625
St Franziskus Hospital GmbH
Münster, 48145
Krankenhaus Barmherzige Bruder Regensburg
Regensburg, 93049
Universitatsklinikum Ulm
Ulm, D-89075

Other trials in Germany

Turkey (Türkiye)3 sites

Baskent University Ankara Hospital
Ankara, 06490
Dokuz Eylul University
Izmir
Ege University Hospital
Izmir

Other trials in Turkey (Türkiye)

Netherlands2 sites

Catharina Ziekenhuis
Eindhoven, 5623 EJ
St. Antonius Ziekenhuis
Nieuwegein, 3435EM

Other trials in Netherlands

Austria1 site

Medical University of Innsbruck
Innsbruck, 6020

Other trials in Austria

Italy1 site

Polyclinic Hospital S.Orsola - Malpighi
Bologna, 40138

Other trials in Italy

Spain1 site

Hospital Clinico Universitario de Valladolid
Valladolid, 47005

Other trials in Spain

United Kingdom1 site

St George's Hospital
London, SW17 0QT

Other trials in United Kingdom

About this study

Official title: VALIANT CAPTIVIA Post-market Registry A Multi-center, Post-market, Non Interventional, Prospective Study

The Valiant Thoracic Stent Graft with the Captivia Delivery System (Valiant Captivia) is designed to treat diseases of the descending thoracic aorta including but not limited to aneurysms and dissections.

The purpose of the VALIANT CAPTIVIA Registry is to collect and evaluate mid term clinical performance data of the Valiant Captivia Thoracic Stent Graft System following OUS market approval.

Read the detailed description

Use of controls
This study is a post-market registry without using a control. All analyses will be descriptive in nature and no statistical comparisons are planned. Sample size
There is no sample size calculation since this is not a hypothesis driven study; VALIANT CAPTIVIA has recruited 100 subjects and will follow these subjects through for approximately 36 months.
Number of investigation sites and study duration
15 investigation sites in Europe and Turkey where the Valiant Captivia Thoracic Stent Graft System is commercially available have enrolled 100 subjects.
There will be no minimum nor maximum number of enrolled subjects per investigation site.
The sites' compliance with the clinical investigation plan will be assessed on an ongoing basis. In case of serious non-compliance, the sponsor may decide to stop subject enrolment in a site based on the assessment.

Conditions: Aortic Aneurysm, Thoracic
Being tested: TEVAR
Keywords: Stent graft, thoracic aorta, dissection, aneurysm, TEVAR, VALIANT, CAPTIVIA, endovascular
Medical subject headings: Aortic Aneurysm, Thoracic, Aneurysm

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TEVARDevice
Also called Valiant Captivia stent graft system
Thoracic endovascular aneurysm repair

Study groups in NCT01181947
Study group	Role	What they receive
patients undergoing TEVAR		Those with a thoracic aortic aneurysm/dissection Receives: Device: TEVAR

What is being measured

The primary outcome is the main question the study is designed to answer.

Treatment Success
technical success and freedom from
- TAA diameter increase of stented segment (>5mm compared to 1 mo),
- Types I/III endoleak,
- Aneurysm rupture,
- Conversion to open surgery,
- Stent graft occlusion,
- Stent graft migration resulting in SAE or secondary intervention.
Measured: at 12 months
Technical Success at Time of Initial Implant
Technical success is defined as successful delivery and deployment of the stent graft (assessed intraoperatively). This is achieved by deployment of the Valiant Thoracic Stent Graft in the planned location with no unintentional coverage of the left subclavian artery, left common carotid artery and/or brachiocephalic artery and with the removal of the delivery system
Measured: intraoperatively

Secondary outcomes (2)

SAE
Serious Adverse Events (SAE)
Measured: through 12 months
ACM and ARM
All-cause (ACM), Aneurysm related (ARM) and dissection related mortality
Measured: at 30 days, 12 months, 24 months and 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2010Aug 2013

First posted13 Aug 2010 (estimated)
Study startFeb 2010
Primary completionMar 2013
Study completionAug 2013

Why it stopped: CIP was amended to include long-term FU but, not all sites accepted it so the nr. of pts participating in the extended FU will be small.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Aortic Aneurysm, ThoracicStudies of the same condition, open and under way.
More trials run by Medtronic CardiovascularThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01181947
Sponsor's protocol ID: MDTEV20112009
Acronym: VCOUS
Status last verified: Jan 2023
First submitted: 10 Aug 2010
Last updated: 8 Nov 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Heijmen RH, Thompson MM, Fattori R, Goktay Y, Teebken OE, Orend KH. Valiant thoracic stent-graft deployed with the new captivia delivery system: procedural and 30-day results of the Valiant Captivia registry. J Endovasc Ther. 2012 Apr;19(2):213-25. doi: 10.1583/11-3652MR.1.
PubMed 22545887

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
GORE® TAG® Thoracic Branch Endoprosthesis Zone 0/1 Post-Approval Study
Aortic Arch Dissection, Aortic Arch Aneurysm
Recruiting
Triple Branched Stent Graft System for Aortic Arch Lesions
Aortic Arch Aneurysm, Aortic Arch Pseudoaneurysm
Enrolling by invitation
Endovascular Treatment of Thoracic Aortic Disease
Thoracic Aortic Aneurysms, Dissecting, Aneurysm
Recruiting
Clinical Study to Evaluate the Safety and Effectiveness of Arcevo LSA
Aortic Arch Aneurysm, Aortic Arch Dissection
Active, not recruitingObservational study
Pulmonary Complications Following TEVAR
Aortic Aneurysm and Dissection, Thoracic Endovascular Aortic Repair

All Aortic Aneurysm, Thoracic trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: VALIANT CAPTIVIA Post-market Registry A Multi-center, Post-market, Non Interventional, Prospective Study
ClinicalTrials.gov ID: NCT01181947
Acronym / sponsor ID: VCOUS / MDTEV20112009
Conditions: Aortic Aneurysm, Thoracic
Keywords: Stent graft, thoracic aorta, dissection, aneurysm, TEVAR, VALIANT, CAPTIVIA, endovascular
Study type: Observational
Recruitment status: TerminatedReason stopped: CIP was amended to include long-term FU but, not all sites accepted it so the nr. of pts participating in the extended FU will be small.
Enrolment: 100 participants (actual)
Lead sponsor: Medtronic CardiovascularIndustry (pharma, biotech, devices)
Study start: Feb 2010
Primary completion: Mar 2013 (actual)
Study completion: Aug 2013 (actual)
First posted: 13 Aug 2010 (estimated)
Results: Posted 26 Jan 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of the VALIANT CAPTIVIA Registry is to collect and evaluate mid term clinical performance data of the Valiant Captivia Thoracic Stent Graft System following OUS market approval.

Detailed description

Use of controls
This study is a post-market registry without using a control. All analyses will be descriptive in nature and no statistical comparisons are planned. Sample size
There is no sample size calculation since this is not a hypothesis driven study; VALIANT CAPTIVIA has recruited 100 subjects and will follow these subjects through for approximately 36 months.
Number of investigation sites and study duration
15 investigation sites in Europe and Turkey where the Valiant Captivia Thoracic Stent Graft System is commercially available have enrolled 100 subjects.
There will be no minimum nor maximum number of enrolled subjects per investigation site.
The sites' compliance with the clinical investigation plan will be assessed on an ongoing basis. In case of serious non-compliance, the sponsor may decide to stop subject enrolment in a site based on the assessment.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
patients undergoing TEVAR	–	Device: TEVARThose with a thoracic aortic aneurysm/dissection

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: The Valiant Thoracic Stent Graft with the Captivia Delivery System is indicated for treatment of diseases of the descending thoracic aorta including but not limited to aneurysms and dissections. The Valiant Thoracic Stent Graft is indicated for exclusion of the aneurysm, the false lumen or site of rupture and restoration of blood flow through the stent graft lumen. The device is intended for use in subjects who are candidates for conventional surgical repair, and in subjects who are not candidates for conventional surgical repair due to pre-existing risk factors. Study enrolment is open to subjects who in the opinion of the investigator are candidates for endovascular TAA repair with the Valiant Captivia Thoracic Stent Graft System according to the instructions for use (IFU).

Key inclusion criteria (5 listed)

Age ≥ 18 years or minimum age as required by local regulations
Indication for surgical repair of thoracic aortic aneurysms and/or thoracic aortic dissections with an thoracic endovascular stent graft in accordance with the applicable guidelines on endovascular interventions and the Instructions for Use of the Valiant Captivia Thoracic Stent Graft System
Signed consent form ('Patient informed consent form' or 'Patient Data Release Authorization Form')
Intention to implant the Valiant Captivia Thoracic Stent Graft System or having implanted the system within the last 3 months before subject enrollment
Willingness and ability to comply with the CIP

Key exclusion criteria (3 listed)

High probability of non-adherence to physician's follow-up requirements
Participation in concurrent interventional trial which may confound study results
Prior implantation of a thoracic stent graft

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TEVARAlso: Valiant Captivia stent graft systemThoracic endovascular aneurysm repair	Device	patients undergoing TEVAR

Primary outcome

Treatment Success
Time frame: at 12 months
technical success and freedom from * TAA diameter increase of stented segment (>5mm compared to 1 mo), * Types I/III endoleak, * Aneurysm rupture, * Conversion to open surgery, * Stent graft occlusion, * Stent graft migration resulting in SAE or secondary intervention.
Technical Success at Time of Initial Implant
Time frame: intraoperatively
Technical success is defined as successful delivery and deployment of the stent graft (assessed intraoperatively). This is achieved by deployment of the Valiant Thoracic Stent Graft in the planned location with no unintentional coverage of the left subclavian artery, left common carotid artery and/or brachiocephalic artery and with the removal of the delivery system

2 secondary outcomes

SAE
Time frame: through 12 months
ACM and ARM
Time frame: at 30 days, 12 months, 24 months and 36 months

Results and safety

Results posted to the registry on 26 Jan 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Patients Undergoing TEVAR	100	100

Primary outcome: Treatment Success

Time frame: at 12 months. Count of participants. Unit: Participants

Measure	1 - Medtronic VCOUS n = 57	2 - Medtronic VCOUS n = 61	3 - Medtronic VCOUS n = 100	4 - Medtronic VCOUS n = 98	5 - Medtronic VCOUS n = 100	6 - Medtronic VCOUS n = 64
Value	9	4	4	0	2	1

Population analysed: The number of participants analyzed are different for each endpoint based on number of evaluable subjects at each timepoint per endpoint.

Primary outcome: Technical Success at Time of Initial Implant

Time frame: intraoperatively. Number (95% Confidence Interval). Unit: participants

Measure	Patients Undergoing TEVAR n = 100
Value	100 (96.4 to 100.4)

Population analysed: The primary and secondary endpoints will be reported descriptively. By-gender and by-race data summaries for the primary endpoints, if appropriate, will be generated. Data from all study sites will be grouped together for analyses.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 12 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
1. VCOUS	48 of 100 (48%)	5 of 100 (5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 22545887Heijmen RH, Thompson MM, Fattori R, Goktay Y, Teebken OE, Orend KH. Valiant thoracic stent-graft deployed with the new captivia delivery system: procedural and 30-day results of the Valiant Captivia registry. J Endovasc Ther. 2012 Apr;19(2):213-25. doi: 10.1583/11-3652MR.1.

Related trials for Aortic Aneurysm, Thoracic

Recruiting
GORE® TAG® Thoracic Branch Endoprosthesis Zone 0/1 Post-Approval Study
Aortic Arch Dissection, Aortic Arch Aneurysm
Recruiting
Triple Branched Stent Graft System for Aortic Arch Lesions
Aortic Arch Aneurysm, Aortic Arch Pseudoaneurysm
Enrolling by invitation
Endovascular Treatment of Thoracic Aortic Disease
Thoracic Aortic Aneurysms, Dissecting, Aneurysm
Recruiting
Clinical Study to Evaluate the Safety and Effectiveness of Arcevo LSA
Aortic Arch Aneurysm, Aortic Arch Dissection
Active, not recruitingObservational study
Pulmonary Complications Following TEVAR
Aortic Aneurysm and Dissection, Thoracic Endovascular Aortic Repair

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Giovanni Torsello, Prof. principal investigator

St Franziskus Hospital GmbH

Rosella Fattori, Prof. principal investigator

Policlinico S.Orsola Malpighi

Carlos Vaquero Puerta, Dr. principal investigator

Hospital Clínico Universitario de Valladolid

15 sites in 7 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Aortic Aneurysm, Thoracic, run by Medtronic Cardiovascular at 15 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 8 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in Germany, Turkey (Türkiye), Netherlands, Austria, Italy and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Jan 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Treatment Success (time frame: at 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01181947, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2023.